Integrated Design Controls with PLM: Why It’s Critical

The product development cycle refers to the various stages involved in the product life cycle, right from design and development to manufacturing, supplier and customer processes, and eventually, product obsolescence. Every stage has a set of processes that ensure the quality, safety, and performance of the product. This quality-first approach requires ongoing reviews, testing, and refinement- often going back and forth between different departments and multi-disciplinary teams.

To ensure product quality and performance, the Food and Drug Administration provides a framework called Design Controls (21 CFR 820.30) that is applicable to all Class II and Class III medical devices and select Class I devices. The Design controls are a set of quality practices and procedures that help with the following:

• Controlling the design process to ensure that the device fulfills:

• User needs
• Intended uses
• Specified requirements

• The design can change/improve and prevent future issues

Integrating Design Controls with the product development lifecycle minimizes quality issues, ensures the product is developed in alignment with the objectives, and improves change management and productivity.

The Iterative Nature of Product Development

The product lifecycle involves different teams coming together to provide inputs at different stages. This makes it a highly risky process as changes are introduced to meet evolving needs, and each time, reviews and approvals are required. The changes need to be shared with all processes upstream and downstream so that they can correspondingly change their processes based on the new needs. This can lead to a lot of confusion and potential errors.

Typically, the following steps are involved in the design and development of a product:

• Step 1. Ideation: In this step, the focus is on identifying the problem the product will solve and what features it must have to enable it. The product could be brand new or a variant of existing products. Therefore, creating a unique selling proposition becomes crucial and requires inputs from all the departments involved, such as sales, marketing, finance, manufacturing, and customer service, to provide inputs on what is needed and what is feasible.
• Step 2. Design: Once the product concept has been formulated, the next step is to design the product by involving engineers and developers who decide on the specifications and draw up the plans. At this stage, the quantity and quality of the raw materials are also finalized along with who will manufacture, how, and other specific details – which are captured in the Bill of Materials – as well as starting to consider who will manufacture it and the cost of materials and parts. Surveys and tests help get consumer inputs to finalize the features and their aesthetics. Quality and safety criteria are also finalized at this stage to ensure conformance and compliance with the final product.
• Step 3. Validation: Before the design and the BOM are transferred to the manufacturing team, it is validated to confirm that the design conforms to the initial ideas that were decided on. Review by all stakeholders confirms and validates the product or changes made to ensure conformance.
• Step 4. Procurement and Manufacturing: The design then moves to manufacturing, where the BOM refers to purchasing materials in the quantity and quality specified. It could be manufactured in-house or outsourced, based on the capability of the manufacturer, and all the documents shared. At this stage, based on the availability of raw materials and the manufacturer's capability, there could be some changes that will again need to be reviewed and approved by all stakeholders.
• Step 5: Sales and Marketing: Meanwhile, the marketing preparations will also begin to create interest in the market and prepare the ground for sales. The target market and pricing would have been decided in Steps 1 and 2. Therefore, the activities must also be tailored accordingly.
• Step 6. Launch and Service: Distributing and selling the product, providing maintenance and service as needed, training and manuals to go with it, and even obsolescence will form part of this stage. Any feedback must be gathered and passed back to the design and development team for continuous improvement of the product.

PLM for Greater Efficiency

Given the many back-and-forths involved in getting every stage of product development right, manual systems can be challenging. They can lead to errors and delays, affecting time to market and device performance and damaging brand reputation.

Therefore, automating the lifecycle using a product lifecycle management platform can help manufacturers gain greater visibility. All stakeholders can collaborate on a single platform with centralized document management that enables version control and a unified view of data and communication. Briefly, some of the benefits of a cloud-based PLM include:

• Unified View: Product development requires multiple systems such as CAD/CAM, ERP, SCM, CRM, etc. Often, these solutions don’t talk to each other, and so, duplication of documents becomes inevitable, leading to errors, data silos, and delays in communication. A PLM solution enables unifying documents and data from all the different solutions onto a centralized location for greater efficiency and version control.
• Lower Errors: The many revisions to the design and BOM documents also require multiple reviews and approvals. In a legacy system, some documents may be missed, causing delays. Also, the presence of multiple versions of the documents can lead to errors and miscommunications, which can be avoided with a unified platform and centralized document management system.
• Faster Time to Market: Improved document, communication, and collaboration will lead to shorter approval cycles and faster time to market with improved quality and performance. This will also lower the cost of manufacturing, leading to improved bottom line, customer satisfaction, and customer engagement.

Role of Integrated Design Control with PLM

Design Controls are a regulatory requirement that demonstrates compliance, product quality, and safety. ISO 13485, section 7.3 covers Design and Development, which is an equivalent of the FDA Design Controls. It requires the maintenance of documentation and records for the entire product development process and is stored in the Design History File (DHF).

The manufacturer is expected to demonstrate linkages and relationships between the various stages of the development process to establish a traceability matrix. It provides a bird’s eye view of the medical device’s life cycle. Apart from demonstrating compliance and conformance, it also reduces product risks and provides an audit trail that can help with continuous improvement.

A cloud-based solution such as ComplianceQuest’s ProductQuest integrates PLM, Quality Management, and Design Controls, empowering the development team with tools to automate the process and be compliant while meeting the business requirements.

To know more, request a demo: https://www.compliancequest.com/online-demo/